1. Field of the Invention
This invention relates to a device for home use detection of cervical and vaginal carcinoma and the like.
2. Description of the Prior Art
Statistics indicate that a large number of women die each year as a result of cervical cancer.
Gynecologists generally agree that a great proportion of these fatalities could have been avoided if the cervical cancer had been diagnosed earlier. In an ideal situation, women would receive a medical check at short intervals so that the existence of cervical and vaginal carcinoma could be readily diagnosed at an early stage of development and remedial action could be taken before the disease reached a critical stage. All too often the existence of abnormal squamous cells is detected at a stage where the only remedial action is a hysterectomy or removal of all or part of the uterus. Even with the provision of a hysterectomy, surgeons have often found that because of the delay in detecting the infection, the operation has not proved successful in halting the progress of this dreaded disease.
There are a number of factors which deter women from frequent medical tests for cervical and vaginal carcinoma. Firstly, the cost involved in providing medical personnel for carrying out an internal examination has escalated over recent years. Therefore, if a woman is to be examined even once every month, the financial burden imposed upon her often becomes prohibitive. Secondly, a certain degree of embarassment is experienced by most women as they undergo such an internal examination. This embarassment is often magnified in view of the existence of relatively few female gynecologists. Thirdly, the time required by a woman to attend a diagnostic clinic often results in a serious problem, particularly if such visits are to be on a frequent basis. In such cases, the woman, if employed, must require considerable time away from the job. Alternatively, the woman may have young children, and if she is to attend a clinic, it becomes necessary for her to engage the services of a babysitter.
In order to overcome the aforementioned problems, a home use detection device for the detection of cervical and vaginal carcinoma offers many attractive advantages. By the provision of a low cost home use device, a woman is able to carry out such a test at least once a month if not several times a month. The present invention contemplates two embodiments of testing wherein the first embodiment requires the test cells to be forwarded by mail or the like to a testing laboratory whereas the second embodiment enables the cells to be immediately testing in the home. In either embodiment, the woman is released from the embarassment from undergoing an internal examination by a medical practitioner. Not only is the woman permitted to carry out the test in the privacy of her own home, but also, she saves herself the high cost of a medical examination and the other various problems associated with such visits to a medical practitioner such as the arrangements needed to care for her children during such visits.
With regard to the actual requirements for the successful diagnosis of cervical and/or vaginal carcinoma, a sample of cervical or vaginal epithelium is taken by the woman herself. Such epithelium is cellular tissue that covers the surfaces and lines the internal walls of the vaginal cavity. In the first embodiment, the epithelium sample is mixed with a fixing solution and is mailed to a pathological laboratory. At the laboratory, the epithelium sample has added thereto an iodine stain which indicates the existence of normal squamous cell epithelium because normal squamous cell epithelium contains glycogen. The iodine stain reacts with the glycogen to provide a visual indication of normal squamous cell epithelium. However, in the case of abnormal squamous cell epithelium, such epitheliums exhibits pathological activity and is thought to contain little or no glycogen. In view of this lack of glycogen, an abnormal sample of epithelium will not demonstrate the same visual indication when iodine stain is added to the same, thus indicating the existence of squamous cell carcinoma. Since squamous cell carcinoma is thought to comprise over 90% of all cervical carcinomas, this method of cancer detection is very desirable.
In the second embodiment, a sample of cervical or vaginal epithelium is again taken by the woman. The epithelium sample is then mixed with an iodine stain which indicates the existence of normal squamous cell epithelium upon the reaction of the iodine stain with the glycogen. Abnormal sample cells contain little or no glycogen and will not react with the iodine stain. Accordingly, in the second embodiment, a color comparison chart is provided to enable the woman to compare the color of the sample cells treated with the iodine stain with the color comparison chart to indicate the existence of abnormal cells.
Various prior art devices have been proposed for carrying out home use detection of abnormal conditions in the function of the human body. Among such prior art devices can be listed equipment for home use detection of blood pressure and home use testing for pregnancy. More particularly, pap smear kits are known in which the kit includes a cotton wool swab for taking up an epithelium sample and a mailing folder for mailing the sample to a cytology laboratory for diagnosis. In the United States alone, seventy million such pap smears are collected each year and are tested for diagnosis of cancer. However, in the majority of such cases, these pap smears are obtained by skilled medical personnel and not by the patient herself. Therefore, it is the primary object of this invention to provide a device for home use detection of cervical and vaginal carcinoma and the like.
Therefore, an object of this invention is the provision of a low cost home use device for obtaining a sample of squamous cell epithelium.
Another object of the present invention is the provision of a device which is convenient to use by a woman to obtain from herself a sample of squamous cell epithelium.
Another object of this invention is the provision of a device which overcomes the problems associated with frequent visits to a medical clinic for internal examinations.
Another object of this invention is the provision of a home use device wherein the testing and the results thereof may be obtained at the home of the user.
Another object of this invention is the provision of a home use device which is easily able to be sent by mail to a pathological laboratory, or more particularly, a cytology laboratory as the cytology laboratory specialized in diagnosis of pap smears.
Another object of the invention is the provision of a tube having a rounded end for insertion within the vagina. A flexible diaphragm cooperates with a plunger for aspirating a sample of squamous epithelium from the vagina into the elongated tube. A fixing container having a rupturable membrane and containing a fixing solution forms a sealing engagement upon insertion of the elongated tube into the cylindrical portion to rupture the membrane and mix the fixing solution with the squamous epithelium from the vagina.
Another object of this invention is the provision of a probe for removing a sample of squamous epithelium from the vagina or cervix. A staining container having a rupturable membrane and containing an iodine stain solution enables the cells present on the probe to be mixed with the iodine stain. The color of the treated cells is then compared to a color comparison chart accompanying the test kit.
The foregoing has outlined some of the more pertinent objects of the present invention. These objects should be construed as being merely illustrative of some of the more prominent features and applications of the invention. Many other beneficial results can be attained by applying the disclosed invention in a different manner or modifying the invention within the scope of the disclosure. Particularly with regard to the use of the invention disclosed herein, this should not be construed as limited to a device for home use detection of cervical and vaginal carcinoma, but should include a disposable device for home use detection of any abnormal condition of the squamous cell epithelium of the vaginal or cervical region.